Senior Regulatory Affairs Specialist (m / w / d)
Based in Munich
My client is a $5 billion in revenue, global leader of medical device products (Class III) based in Munich, who are looking for a Senior Regulatory Affairs Specialist/Manager to join their team of 5 colleagues. They are focused on the MDR transition, and new devices coming to market being approved under the new regulations. Then, the opportunity for international registrations. This is a truly global RA role, while still being an expert in the EU market, and there is a huge opportunity here to continue to be a prominent figure in Regulatory Affairs.
- Strategic preparation and processing of global regulatory approvals for market-leading medical products
- Device launches in EU/USA under the MDR and FDA
- Management of the technical file documentation for international approvals in the EU and US
- Collaborate on risk management for medical devices under ISO 14971
- Supporting on the MDR transition, and regular contact with notified bodies
- A close partnership with other departments for a quick and efficient product launch in multiple markets
- Degree educated in scientific studies or engineering
- 2-4 years of experience in regulatory affairs at a medical device company, specialising in active medical devices
- Working knowledge of the MDD/MDR
- Fluent in German, with very good spoken and written English
- Experience working with ISO 13485 and EN60601
Please apply with your CV or contact the job poster Rebecca Woodfield for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+44 208 638 5376